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Axogen Seeks FDA Approval For Avance Nerve Graft

 
• By Reed Miller

Supported by results from the RECON trial, the Florida company will file a biologics license application for its Avance nerve graft used surgical repair of finger injuries

Avance Nerve Graft Circle
AXOGEN'S AVANCE NERVE GRAFT • Source: Axogen Inc.

Axogen is on track to seek US Food and Drug Administration approval for its Avance nerve graft device by the end of next year.

Avance is a biologically active, “off-the-shelf,” decellularized human nerve allograft that bridges severed peripheral nerves. It provides “structural guidance” to allow the body to regenerate axons – the nerve fibers that carry electrical impulses from one neuron to another – while revascularizing and remodeling into the patient’s own tissue

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• By Marion Webb

Peerbridge Health is preparing to submit its next-generation ECG patch, CorMDx, for US FDA clearance this quarter, with plans to launch in the second half of 2025. The rechargeable device is designed for continuous, real-time heart monitoring from the hospital to home, aiming to detect early signs of heart failure and reduce emergency room visits.

Subsense Develops Nonsurgical, Nanoparticle-Based Brain-Computer Interface For Neurological Disorders

 
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AAOS 2025 Orthopedic Roundup: J&J Velys UKA, Stryker Mako 4, Materialise, Canary Medical

 
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LSX Roundup: Startups Elypta, QuantiLight And Plexaa Debut New Tech

 
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More from R&D

No Knife, No Burn, Just Bubbles: HistoSonics Hits 90% Tumor Control In #HOPE4Liver Trial, Eyes IPO Timing

 
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HistoSonics, which developed a noninvasive technology to destroy tumor cells, reports 90% local tumor control at 12-month follow-up in the #HOPE4Liver Trial. The Edison System, cleared by the US FDA in late 2023, is also being evaluated for kidney and pancreatic tumors. CEO Mike Blue said the medtech is financially secure but watching public markets as it considers an IPO.

Medtronic Presents Data To Boost Hugo’s Odds Of Getting FDA Nod

 
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First Liver Cancer Surveillance Test In Five Years Receives FDA Breakthrough Status

 
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